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Long-term Efficacy and Safety Study of GV-971

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sodium Oligomannate Capsules (GV-971)
Sponsored by
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 50 to 85 years (inclusive), with no restriction on gender;
  2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
  3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
  4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
  5. Patients receiving GV-971 treatment prescribed by clinicians;
  6. Sign the informed consent form.

Exclusion Criteria:

  1. Patients who have received GV-971 treatment within 6 months prior to screening;
  2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
  3. Female participants who are pregnant or lactating;
  4. Patients who cannot cooperate to complete the follow-up inquiries;
  5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Sites / Locations

  • Beijing Chao-Yang Hospital
  • Peking University People's Hospital
  • Peking University Shougang Hospital
  • Peking University Third Hospital
  • The First Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Lanzhou University Second Hospital
  • The First Hospital of Lanzhou University
  • The First People's Hospital of Foshan
  • Nanfang Hospital
  • The Affiliated Brain Hospital of Guangzhou Medical University
  • Peking University Shenzhen Hospital
  • Shenzhen People's Hospital
  • The Affiliated Hospital of Guizhou Medical University
  • No.6 HeBei Provincial People's Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhongnan Hospital of Wuhan University
  • The First Hospital of Changsha
  • The Second Affiliated Hospital of Nanjing Medical University
  • Wuxi Mental Health Center
  • Wuxi No.2 People's Hospital
  • Northern Jiangsu People's Hospital
  • Affiliated Zhongshan Hospital of Dalian University
  • The Second Hospital of Dalian Medical University
  • Central Hospital Affiliated to Shandong First Medical University
  • The Second Hospital of Shandong University
  • The Affiliated Hospital of Qingdao University
  • Shanghai 6th People's Hospital
  • Shanghai East Hospital
  • Shanghai Mental Health Center
  • Tongren Hospital Shanghai Jiao Tong University School Of Medicine
  • Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
  • Zhongshan Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
  • West China School of Medicine/West China Hospital of Sichuan University
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • The Affiliated Hospital of Hangzhou Normal University
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Tongde Hospital of Zhejiang Province
  • Zhejiang Hospital
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium Oligomannate Capsules (GV-971)

Arm Description

The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening

Outcomes

Primary Outcome Measures

Change from baseline in the ADAS-cog/11 score
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.

Secondary Outcome Measures

Change from baseline in ADAS-Cog/11 score
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Change from baseline in MMSE score
Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.
Change from baseline in ADCS-ADL score
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971.

Full Information

First Posted
December 2, 2021
Last Updated
May 25, 2023
Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05181475
Brief Title
Long-term Efficacy and Safety Study of GV-971
Official Title
A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Oligomannate Capsules (GV-971)
Arm Type
Experimental
Arm Description
The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Intervention Type
Drug
Intervention Name(s)
Sodium Oligomannate Capsules (GV-971)
Intervention Description
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
Primary Outcome Measure Information:
Title
Change from baseline in the ADAS-cog/11 score
Description
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Time Frame
Baseline, 48 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in ADAS-Cog/11 score
Description
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Time Frame
Baseline, 96 weeks
Title
Change from baseline in MMSE score
Description
Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.
Time Frame
Baseline, 48 weeks, 96 weeks
Title
Change from baseline in ADCS-ADL score
Description
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Time Frame
Baseline, 48 weeks, 96 weeks
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971.
Time Frame
48 weeks, 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 50 to 85 years (inclusive), with no restriction on gender; Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria; Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive; Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol; Patients receiving GV-971 treatment prescribed by clinicians; Sign the informed consent form. Exclusion Criteria: Patients who have received GV-971 treatment within 6 months prior to screening; Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator; Female participants who are pregnant or lactating; Patients who cannot cooperate to complete the follow-up inquiries; Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Affiliated Brain Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
No.6 HeBei Provincial People's Hospital
City
Baoding
State/Province
Hebei
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Central Hospital Affiliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China School of Medicine/West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Tongde Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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Long-term Efficacy and Safety Study of GV-971

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